Job Description

Clinical Research Associate position overseeing immunology study sites for compliance with GCP standards and regulatory requirements. Manages site relationships, conducts monitoring activities, and ensures data integrity across assigned protocols in the United States, with significant travel requirements.

Responsibilities

• Develop and maintain site relationships throughout trial phases; ensure regulatory compliance with ICH-GCP and sponsor SOPs
• Conduct remote and on-site monitoring visits including validation, initiation, and close-out activities
• Identify and resolve site performance, quality, or compliance issues; escalate as needed through defined pathways
• Manage study documentation in CTMS and eTMF systems; coordinate with regulatory, finance, and operational teams
• Identify potential new sites and develop clinical research capabilities aligned with country strategy

Requirements

• Associate's degree in scientific/healthcare field plus 5+ years healthcare experience with 2+ years site management, OR Bachelor's degree plus 2+ years site management experience
• Direct site monitoring and management experience in bio/pharma or CRO environment
• Knowledge of ICH-GCP guidelines, clinical trial phases, and country clinical research regulations
• Demonstrated proficiency with clinical data systems, documentation practices, and MS Office
• Strong communication skills in English and local language; ability to work independently across multiple protocols
• Willingness to travel domestically and internationally 65-75% of time; valid driver's license required
• Immunology experience preferred

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